Spots Global Cancer Trial Database for Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
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Trial Identification
Brief Title: Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
Official Title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
Study ID: NCT00689936
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Detailed Description: CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease \[PD\] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of AL Birmingham, Birmingham, Alabama, United States
Cedar Sinai Medical Center Dept of Medicine, Los Angeles, California, United States
University of California, San Francisco- California, San Francisco, California, United States
Stanford University Stanford, Stanford, California, United States
Gainesville Heme Oncology Associates, Gainesville, Florida, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
Integrated Community Oncology Network, Orange Park, Florida, United States
Gulf Coast Oncology, Saint Petersburg, Florida, United States
Palm Beach Cancer Institute, LLC, West Palm Beach, Florida, United States
Southern Illinois Hematology Oncology, Centralia, Illinois, United States
Orchard Healthcare Research, Inc., Chicago, Illinois, United States
John H Stroger Hospital of Cook County, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Ingalls Cancer Institute, Harvey, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Maine Center for Cancer Medicine Blood Disorders, Scarborough, Maine, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Billings Clinic, Billings, Montana, United States
Arena Oncology Associates, PC, Lake Success, New York, United States
Dakota Cancer Institute, Fargo, North Dakota, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Kaiser Permanente Northwest Oncology Hematology, Portland, Oregon, United States
St. Luke's Hospital and Health Network, Allentown, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
The Cancer Center, Collierville, Tennessee, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology, E. Melbourne, Victoria, Australia
Western Hospital, Footscray, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Flinders Medical Centre, Bedford Park, , Australia
Geelong Hospital, Geelong, , Australia
Gosford Hospital, Gosford, , Australia
Royal Brisbane and Women's Hospital, Herston, , Australia
Cabrini Hospital, Malvern, , Australia
The Royal Melbourne Hospital, Parkville, , Australia
Royal Perth Hospital, Perth, , Australia
Gold Coast Hospital, Southport, , Australia
Royal North Shore Hospital, St Leonards, , Australia
Westmead Hospital, Wentworthville, , Australia
Border Medical Oncology, Wodonga, , Australia
Wollongong Hospital, Wollongong, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Hospital Leoben, Leoben, , Austria
Hospital of Barmherzige Schwestern Linz, Linz, , Austria
Hospital of Elisabethinen Linz, Linz, , Austria
General Hospital Linz, Linz, , Austria
MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III, Salzburg, , Austria
Hospital St. Polten, St. Pölten, , Austria
Hospital of the Barmherzigen Bruder Vienna, Vienna, , Austria
MM-015.Wihelminenspital, Vienna, , Austria
MM-015. Medizinische Universität Wien, Vienna, , Austria
Hospital Wels, Wels, , Austria
Hospital Wiener Neustadt, Wiener Neustadt, , Austria
ZNA Stuivenberg Centrumziekenhuis, Antwerpen, , Belgium
Les Cliniques du Sud Luxembourg, Arlon, , Belgium
AZ St-Jan Brugge Oostende AV, Brugge, , Belgium
Hopital Erasme, Brussels, , Belgium
AZ-VUB, Brussels, , Belgium
Jules Bordet Institut, Brussel, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
Virga Jesse Ziekenhuis, Hasselt, , Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven, , Belgium
H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat, Roeselare, , Belgium
Cliniques Universitaires UCL de Mont-Godine, Yvoir, , Belgium
University of Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Kelowna, British Columbia, Canada
Royal Columbian Hospital, New Westminster, British Columbia, Canada
BC Cancer Agency - Fraser Valley Centre, Surrey, British Columbia, Canada
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp, Vancouver, British Columbia, Canada
Vancouver Island Cancer Center, Victoria, British Columbia, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Science Centre, London, Ontario, Canada
Ottawa Hospital, Ottawa, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hospital Charles LeMoyne, Greenfield Park, Quebec, Canada
Hopital de la Cite-de-la-Sante, Laval, Quebec, Canada
Hotel-Dieu de Levis, Levis, Quebec, Canada
Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
Hospital Maisonneuve - Rosemont, Montreal, Quebec, Canada
CHUM- Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish Genl, Montreal, Quebec, Canada
CHUQ - Hotel-Dieu de QuebecHematology - Oncology, Quebec, , Canada
Chaoyang Hospital, Beijing, , China
Peking University People's Hospital, Beijing, , China
West China Hospital of Sichuan University, Chengdu, , China
Ruijin Hospital Shanghai Jiaotong University, Shanghai, , China
Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Tianjin, , China
Clinique Claude BernardOncologie, Albi, , France
CHU Sud, Amiens, , France
CHRU Hopital du bocage, Angers cedex 01, , France
CH Argenteuil Victor Dupouy, Argenteuil, , France
Centre Hospitalier de la cote basque, Bayonne, , France
Centre Hospitalier, Blois cedex, , France
Hopital Avicenne, Bobigny Cedex, , France
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Hopital de Fleyriat, Bourg en Bresse cedex, , France
Hopital Augustin Morvan, Brest cedex, , France
Centre Francois Baclesse, Caen cedex 5, , France
CHU, Caen, , France
CH, Cannes Cedex, , France
CH Rene Dubois, Cergy-Pontoise, , France
Centre Hospitalier William Morey, Chalon/Saone Cedex, , France
Hopital dinstruction des armees Percy, Clamart Cedex, , France
Hopital Antoine Beclere, Clamart, , France
Chu Estaing, Clermont Ferrand, , France
CH Louis Pasteur, Colmar cedex, , France
Hopital Henri Mondor, Creteil, , France
CHRU Hopital du bocage, Dijon, , France
Centre Hospitalier General, Dunkerque, , France
CHRU, Grenoble cedex 09, , France
Institut Prive de Cancerologie, Grenoble, , France
Centre Hospitalier Departemental, La Roche -Sur-Yon cedex 9, , France
CH, Le Chesnay Cedex, , France
Hopital J MonodRhumato Nord, Le Havre, , France
Kremlin Bicetre, Le Kremlin bicetre CDX, , France
Centre Hospitalier, Le Mans cedex, , France
Centre Jean Bernard, Le Mans, , France
CHRU-Hopital Claude Huriez, Lille cedex, , France
GH de Institut Catholique St Vincent, Lille, , France
CH - Hôpital Dupuytren, Limoges Cedex 1, , France
CHU Hopital Edouard Herriot, Lyon cedex, , France
Centre Leon Berard, Lyon, , France
Centre Hospitalier de Valence, Lyon, , France
Institut Paoli-Calmettes, Marseille Cedex 9, , France
Hopital de Mercy, METZ cedex 3, , France
Clinique Pont de chaume Oncologie et Radiotherapie, Montauban cedex, , France
CHU Montpellier - Hôpital Lapeyronie, Montpellier Cedex 5, , France
Hopital Emile Muller, Mulhouse, , France
CHRU - Hotel Dieu, Nantes, , France
Centre Antoine Lacassagne Oncologie medicale et Hematologie, Nice cedex 1, , France
Hopital de lArchet 1, Nice cedex 3, , France
CH La Source, Orleans, , France
Hopital Cochin, Paris Cedex 14, , France
Hopital Saint Louis, Paris, , France
Hopital Necker, Paris, , France
CHU Hôpital St-Antoine, Paris, , France
CHRU - Hopital du Haut Leveque, Pessac, , France
CU CHU Clemenceau, Poitiers cedex, , France
Hopital R. Debre, Reims cedex, , France
CHU Reims - Hôpital Maison Blanche, Reims, , France
CHRU Hopital sud Medecine Interne, Rennes cedex 02, , France
CHRU Hôpital de Pontchaillou, Rennes Cedex, , France
CHG Rodez, Rodez, , France
Centre Henri Becquerel, Rouen cedex, , France
Centre Rene Huguenin, Saint Cloud, , France
Institut de Cancerologie de Loire, St Priest en Jarez, , France
Centre Hospitalier Yves Le Foll, St-Brieuc cedex 1, , France
CHRU Hôpital de Hautepierre, Strasbourg, , France
CHRU Hopital Purpan, Toulouse cedex 9, , France
CHRU Hopital Bretonneau, Tours cedex, , France
CHRU Hopital Trousseau, Tours, , France
CHRU Hôpitaux de Brabois, Vandoeuvre Cedex, , France
CH P. Chubert, Vannes cedex, , France
Institut Gustave Roussy, Villejuif, , France
Medizinische Kinik und Poliklinik I, Dresden, , Germany
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, Dusseldorf, , Germany
Universitatsklinikum Essen-, Essen, , Germany
Staedtische Kliniken Frankfurt am Main Hochst, Frankfurt am Main, , Germany
Universitatsklinikum Giessen, Giessen, , Germany
Ernst-Moritz-Arndt-Universität Greifswald, Greifswald, , Germany
Askepios Klinik St. Georg, Hamburg, , Germany
Universitatsklinikum Jena, Jena, , Germany
Medizinische Klinik und Poliklinik II, Leipzig, , Germany
Universitatsklinikum schleswig-Holstein, Lübeck, , Germany
Poliklinik A, Muenster, , Germany
Klinikum der Johann-Wolfgang-Goethe-Universtat, München, , Germany
Medizinische Klinik III Klinikum der Universität München-Großhadern, München, , Germany
Medizinische Fakultat der Universitat Rostock, Rostock, , Germany
Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH, Stuttgart, , Germany
Medizinische Klinik - Abteilung II, Tübingen, , Germany
Klinik fur Innere Medizin III, Ulm, , Germany
Alexandra Hospital, University of Athens, Athens, , Greece
Attiko Hospital of Athens, Athens, , Greece
Evangelismos Hospital of Athens, Athens, , Greece
University of Athens, Athens, , Greece
Metaxa Hospital Peiraias, Piraeus, , Greece
Theagenio Anticancer Hospital of Thessaloniki, Thessaloniki, , Greece
Adelaide and Meath Hospital, Dublin, , Ireland
Mater Misercordiae Hospital, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
Policlinico S. Orsola, Bologna, , Italy
Oncologia Medica, Università della Magna Grecia, Catanzaro, , Italy
Clinica Ematologica, A.O.U. San Martino di Genova, Genova, , Italy
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce, Lecce, , Italy
Unità Operativa di Oncoematologia, Ospedale di Matera, Matera, , Italy
U.O. di Ematologia e Trapianto di Midollo Osseo, Milano, , Italy
Istituto Europeo di Oncologia - IEO, Milano, , Italy
Presidio Ospedaliero A. Perrino, Milano, , Italy
Policlinico di Modena, Modena, , Italy
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
Casa di Cura La Maddalena, Divisione di Ematologia, Palermo, , Italy
Policlinico San Matteo Universita Di Pavia, Pavia 2, , Italy
Ospedale Civile, Piacenza, , Italy
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia, Pisa, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali, Roma, , Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma, Rome, , Italy
Ospedale Molinette, Torino, , Italy
Hallym University Sacred Heart Hospital, Anyang, , Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Daegu Catholic University Medical Center 3056-6, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejon, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Hwasun Chonnam National University Hospital, Hwasun-goon, , Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Chonbuk National University Hospital 42, Jeonju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Severance Hospital, Seongsanno, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Auckland City Hospital, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Wellington Hospital, Newtown, , New Zealand
Hospital de Sao Marcos, Braga, , Portugal
Hospitais da Universidade de Coimbra, Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa, Lisboa, , Portugal
Hospital de Santa Maria, Lisboa, , Portugal
Instituto Português de Oncologia Porto, Porto, , Portugal
Hospital de Santo Antonio- Porto, Porto, , Portugal
Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona), , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Instituto Catalan de Oncologia-Hospital Duran, Barcelona, , Spain
Hospital Reina Sofia, Cordoba, , Spain
Hospital Univ. Josep Trueta, Girona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital General Universitario Morales Messeguer, Murcia, , Spain
Hospital Clinico Virgen de la Victoria, Málaga, , Spain
Hospital Son Llatzer, Palma de Mallorca, , Spain
Clinica Universitaria de Navarra,, Pamplona, , Spain
Hospital Sant Pau, Reus, , Spain
Hospital de Donosti, San Sebastian, , Spain
Hospital Universtario Marques de Valdecilla, Santander, , Spain
Hospital Clinico Santiago de Compostela, Santiago de Compostela, , Spain
Hosptial La Fe, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Linkoping University Hospital, Linkoping, , Sweden
Karolinska University HospitalSolna, Stockholm, , Sweden
St. Görans Hospital, Stockholm, , Sweden
Karolinska University Hospital Huddinge, Stockholm, , Sweden
Abteilung Onkologie Haematologie des Kantonsspitals Aarau, Aarau, , Switzerland
UniversitatsSpital Basel, Basel, , Switzerland
Inselsspital Bern, Berne, , Switzerland
Kantonsspital Graubunden, Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois CHUV, Lausanne, , Switzerland
Kantonsspital Munsterlingen, Münsterlingen (TG), , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
China Medical University Hospital, Taichung City, , Taiwan
Veteran General Hospital - Taipei, Taipei, , Taiwan
National Taiwan University Hospital, Tapei, , Taiwan
Gwynedd Hospital, Bangor, , United Kingdom
Royal United Hospital, Bath, , United Kingdom
Belfast City Hospital Haematology Department, Belfast Northern Ireland, , United Kingdom
Birminghman QE, Birmingham West Midlands, , United Kingdom
Royal Bournemouth Hosp, Bournemouth Dorset, , United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
University Hospital of Wales - Cardiff, Cardiff, , United Kingdom
The Beatson West of Scotland Centre, Glasgow, , United Kingdom
Dept of Haematology St Bartholomews Hospital, London, , United Kingdom
Guy's and St Thomas' Hospital - London, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Churchhill Hospital, Oxford, , United Kingdom
Derriford Hospital, Plymouth Crownhill Devon, , United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust, Sheffield, , United Kingdom
Pinderfields General Hospital, West Yorkshire, , United Kingdom
New Cross Hospital- Wolverhampton, Wolverhampton, , United Kingdom
Contact Details
Name: Christian Jacques, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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